DISPOSABLE BIOPROCESSING SYSTEMS Tai Lieu Chat Luong DISPOSABLE BIOPROCESSING SYSTEMS S arfaraz K N i a z i Boca Raton London New York CRC Press is an imprint of the Taylor & Francis Group, an informa business CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2012 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S Government works Version Date: 20111114 International Standard Book Number-13: 978-1-4398-6695-5 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use The authors and publishers have attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if 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arranged Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com To Merlot Sinatra Niazi, the master of disposable emotions Contents Disclaimer xiii Preface xv Author xxi The Bioprocessing Industry—An Introduction Summary 11 Appendix I: Complete Lines of Disposable Systems 18 Chromatography Columns 21 Safety of Disposable Systems 23 Polymers and Additives 24 Material Selection 26 Testing 27 Partnering with Vendors 29 Responsibility of Sponsors 30 Regulatory Requirements 30 United States and Canada 31 Europe 31 Risk Assessment 32 Appendix I: Use of International Standard ISO-10993 “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing” 38 Background 38 International Guidance and Standards 39 Containers 45 Proprietary Bag Suppliers 45 Generic Bag Suppliers 46 Tank Liners 48 2D Fluid Containers 49 2D Powder Bags 49 3D Bags 49 Transportation Container 50 Summary 51 Mixing Systems 53 Types of Mixing 54 Stirring Magnetic Mixer 55 Stirring Mechanical Coupling Mixer 55 Tumbling Mixer 56 Oscillating Mixer 56 vii viii Contents Peristaltic Mixer 57 Summary 57 Disposable Bioreactors 61 Xcellerex Bioreactor 65 Cellexus Bioreactor 68 CELL-Tainer Cell Culture System 68 Wave-Mixed Bioreactors 69 Stirred Single-Use Bioreactors 72 Integrity™ PadReactor™ 73 CellReady Bioreactor 74 Orbitally Shaken Single-Use Bioreactors 74 Bioreactor Selection 75 The Game Changers in Disposable Bioreactor Industry 76 Appendix I Current Literature Survey of the Use of Disposable Systems 81 Connectors and Transfers 121 Tubing 122 Fittings and Accessories 125 Pumps 127 Aseptic Coupling 129 Aseptic Connectors 129 Welding 131 Aseptic Transfer Systems 132 Tube Sealers 133 Sampling 133 Conclusion 134 Controls 137 Sampling Systems 138 TRACE System 139 Optical Sensors 140 Biomass Sensors 144 Electrochemical Sensors 145 Pressure Sensors 146 Conclusions 148 Downstream Processing 149 The Case of Monoclonal Antibodies: A GE Report 150 Membrane Chromatography 154 Virus Removal 156 Buffers 161 Fluid Management 163 Bioseparation 164 Contents ix Depth Filtration 165 Ultrafiltration 165 Integrated Systems 166 Filling and Finishing Systems 169 Robert Bosch Packaging Systems 170 PDC Aseptic Filling Systems 175 Summary 178 10 Filtration 179 Dead-End Filtration 179 Cross-Flow Filtration 180 Filtration Media 181 Polymer Membranes 183 Microfiltration Cross-Flow 187 BioOptimal MF-SL™ 188 TechniKrom™ 188 GE Healthcare 188 Spectrum 188 Conclusion 189 11 Regulatory Compliance 191 Regulatory Barriers 193 Irradiation and Sterilization Validation 194 12 Environmental Concerns 203 Biosafety 203 Liquid Waste 208 Incineration 208 Pyrolysis 209 Grind and Autoclave 210 Landfill 211 Treatment 211 Overall Environmental Impact 212 Summary 212 Appendix B: Classification of Human Etiologic Agents on the Basis of Hazard 214 Appendix B-I: Risk Group (RG1) Agents 214 Appendix B-II: Risk Group (RG2) Agents 215 Appendix B-II-A: Risk Group (RG2)—Bacterial Agents Including Chlamydia 215 Appendix B-II-B: Risk Group (RG2)—Fungal Agents 216 Appendix B-II-C: Risk Group (RG2)—Parasitic Agents 217 Appendix B-II-D: Risk Group (RG2)—Viruses 218 Appendix B-III: Risk Group (RG3) Agents 219 x Contents Appendix B-III-A: Risk Group (RG3)—Bacterial Agents Including Rickettsia 220 Appendix B-III-B: Risk Group (RG3)—Fungal Agents 220 Appendix B-III-C: Risk Group (RG3)—Parasitic Agents 220 Appendix B-III-D: Risk Group (RG3)—Viruses and Prions 220 Appendix B-IV: Risk Group (RG4) Agents 221 Appendix B-IV-A: Risk Group (RG4)—Bacterial Agents 221 Appendix B-IV-B: Risk Group (RG4)—Fungal Agents 221 Appendix B-IV-C Risk Group (RG4)—Parasitic Agents 221 Appendix B-IV-D Risk Group (RG4)—Viral Agents 222 Appendix B-V: Animal Viral Etiologic Agents in Common Use 222 Appendix B-V-1: Murine Retroviral Vectors 223 Appendix K: Physical Containment for Large-Scale Uses of Organisms Containing Recombinant DNA Molecules 223 Appendix K-I: Selection of Physical Containment Levels 224 Appendix K–II: Good Large-Scale Practice (GLSP) .225 Appendix K-III: Biosafety Level (BL1)—Large Scale 226 Appendix K-IV: Biosafety Level (BL2)—Large Scale 227 Appendix K-V: Biosafety Level (BL3)—Large Scale 229 Appendix K-VI: Footnotes of Appendix K 232 Appendix K-VII: Definitions to Accompany Containment Grid and Appendix K 235 13 Epilogue 237 Large Scale 238 Integrity 239 Flexibility 239 Universal Use 240 Scale-Up 241 Cost 241 Out of Steam 242 Validation 242 Leachables 242 Animal Origins 243 The Stainless Challenge 243 Standardization 243 Upstream 244 Compliance 244 High-Expression Cell Lines 245 Flexible Factories 245 Small Companies 246 Unitary Systems 246 Biosafety 247 Autoclaves 247 SIP/CIP 248 276 Bibliography Murphy, T and Schmidt, J Animal-derived agents in 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